US6319210B1 - Methods and apparatus for expressing body fluid from an incision - Google Patents
Methods and apparatus for expressing body fluid from an incision Download PDFInfo
- Publication number
- US6319210B1 US6319210B1 US09/586,969 US58696900A US6319210B1 US 6319210 B1 US6319210 B1 US 6319210B1 US 58696900 A US58696900 A US 58696900A US 6319210 B1 US6319210 B1 US 6319210B1
- Authority
- US
- United States
- Prior art keywords
- incision
- skin
- blood
- housing
- fluid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150076—Means for enhancing collection by heating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
- A61B5/150061—Means for enhancing collection
- A61B5/150083—Means for enhancing collection by vibration, e.g. ultrasound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15109—Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
- A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B2010/008—Interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00743—Type of operation; Specification of treatment sites
- A61B2017/00747—Dermatology
- A61B2017/00765—Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
Definitions
- Lancets in conventional use generally have a rigid body and a sterile needle which protrudes from one end.
- the lancet may be used to pierce the skin, thereby enabling the collection of a blood sample from the opening created.
- the blood is transferred to a test device or collection device. Blood is most commonly taken from the fingertips, where the supply is generally excellent.
- the nerve density in this region causes significant pain in many patients. Sampling of alternate site, such as earlobes and limbs, is sometimes practiced to access sites which are less sensitive. These sites are also less likely to provide excellent blood samples and make blood transfer directly to test devices difficult.
- Haynes U.S. Pat. No. 4,920,977 describes a blood collection assembly with lancet and microcollection tube. This device incorporates a lancet and collection container in a single device. The lancing and collection are two separate activities, but the device is a convenient single disposable unit for situations when sample collection prior to use is desirable. Similar devices are disclosed in Sarrine U.S. Pat. No. 4,360,016, and O'Brien U.S. Pat. No. 4,924,879.
- the invention also relates to a device for expressing body fluid from a lanced skin surface, which comprises a housing and a stimulator member mounted on the housing at an end thereof.
- the stimulator member comprises a coil spring which is compressible toward the housing in response to being pushed against a user's skin in surrounding relationship to a lanced portion thereof.
- FIG. 18 Depicted in FIG. 18 is an alternative embodiment similar to that depicted in FIGS. 1-6, except that the lower end surface of the outer stimulator ring 64 D is provided with a hollow stimulator element 114 which is electrically connected to a battery 116 mounted in an upper end of the device.
- the element can be either an electrical resistance element (i.e., a heater) or a vibrator such as a piezoelectric transducer, intended to stimulate fluid flow.
- a heater will expand the capillaries and make the blood or interstitial fluid less viscous and thus more flowable, in order to increase the amount of the body fluid sample.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Veterinary Medicine (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Public Health (AREA)
- Physics & Mathematics (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Emergency Medicine (AREA)
- Optics & Photonics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Description
Claims (2)
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/586,969 US6319210B1 (en) | 1996-05-17 | 2000-06-05 | Methods and apparatus for expressing body fluid from an incision |
US09/960,806 US20020010406A1 (en) | 1996-05-17 | 2001-09-21 | Methods and apparatus for expressing body fluid from an incision |
US10/607,347 US7841991B2 (en) | 1996-05-17 | 2003-06-26 | Methods and apparatus for expressing body fluid from an incision |
US12/938,784 US20110046515A1 (en) | 1996-05-17 | 2010-11-03 | Methods and apparatus for expressing body fluid from an incision |
US13/561,672 US8740813B2 (en) | 1996-05-17 | 2012-07-30 | Methods and apparatus for expressing body fluid from an incision |
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US1713396P | 1996-05-17 | 1996-05-17 | |
US1991896P | 1996-06-14 | 1996-06-14 | |
US2365896P | 1996-08-01 | 1996-08-01 | |
US2534096P | 1996-09-03 | 1996-09-03 | |
US08/858,043 US5951493A (en) | 1997-05-16 | 1997-05-16 | Methods and apparatus for expressing body fluid from an incision |
US09/238,140 US6071250A (en) | 1997-05-16 | 1999-01-28 | Methods and apparatus for expressing body fluid from an incision |
US09/586,969 US6319210B1 (en) | 1996-05-17 | 2000-06-05 | Methods and apparatus for expressing body fluid from an incision |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/238,140 Continuation US6071250A (en) | 1996-05-17 | 1999-01-28 | Methods and apparatus for expressing body fluid from an incision |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/960,806 Continuation US20020010406A1 (en) | 1996-05-17 | 2001-09-21 | Methods and apparatus for expressing body fluid from an incision |
Publications (1)
Publication Number | Publication Date |
---|---|
US6319210B1 true US6319210B1 (en) | 2001-11-20 |
Family
ID=25327335
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/858,043 Expired - Lifetime US5951493A (en) | 1996-05-17 | 1997-05-16 | Methods and apparatus for expressing body fluid from an incision |
US09/238,140 Expired - Lifetime US6071250A (en) | 1996-05-17 | 1999-01-28 | Methods and apparatus for expressing body fluid from an incision |
US09/586,969 Expired - Lifetime US6319210B1 (en) | 1996-05-17 | 2000-06-05 | Methods and apparatus for expressing body fluid from an incision |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/858,043 Expired - Lifetime US5951493A (en) | 1996-05-17 | 1997-05-16 | Methods and apparatus for expressing body fluid from an incision |
US09/238,140 Expired - Lifetime US6071250A (en) | 1996-05-17 | 1999-01-28 | Methods and apparatus for expressing body fluid from an incision |
Country Status (1)
Country | Link |
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US (3) | US5951493A (en) |
Cited By (113)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20020188223A1 (en) * | 2001-06-08 | 2002-12-12 | Edward Perez | Devices and methods for the expression of bodily fluids from an incision |
US20030199893A1 (en) * | 2002-04-19 | 2003-10-23 | Pelikan Technologies, Inc. | Method and apparatus for a multi-use body fluid sampling device with analyte sensing |
US6645219B2 (en) * | 2001-09-07 | 2003-11-11 | Amira Medical | Rotatable penetration depth adjusting arrangement |
US20030212424A1 (en) * | 2002-04-19 | 2003-11-13 | Pelikan Technologies, Inc. | Method and apparatus for lancet actuation |
US6706000B2 (en) * | 1997-11-21 | 2004-03-16 | Amira Medical | Methods and apparatus for expressing body fluid from an incision |
US20040127819A1 (en) * | 2002-12-30 | 2004-07-01 | Roe Steven N. | Blood acquisition suspension system |
US20040127929A1 (en) * | 2002-12-30 | 2004-07-01 | Roe Steven N. | Flexible test strip lancet device |
WO2004060159A1 (en) * | 2002-12-27 | 2004-07-22 | Roche Diagnostics Gmbh | Precision depth control lancing tip |
US20040186394A1 (en) * | 2003-01-29 | 2004-09-23 | Roe Steven N. | Integrated lancing test strip |
US20040197231A1 (en) * | 2001-07-27 | 2004-10-07 | Koji Katsuki | Analyzing instrument |
US20040249253A1 (en) * | 2003-06-06 | 2004-12-09 | Joel Racchini | Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein |
US20040248312A1 (en) * | 2003-06-06 | 2004-12-09 | Bayer Healthcare, Llc | Sensor with integrated lancet |
US20040249254A1 (en) * | 2003-06-06 | 2004-12-09 | Joel Racchini | Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein |
US20040253736A1 (en) * | 2003-06-06 | 2004-12-16 | Phil Stout | Analytical device with prediction module and related methods |
US20050049522A1 (en) * | 2002-10-30 | 2005-03-03 | Allen John J | Method of lancing skin for the extraction of blood |
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US20050234492A1 (en) * | 2004-03-15 | 2005-10-20 | Tsai Fu H | Lancet device and method of use |
US20050234368A1 (en) * | 2004-04-15 | 2005-10-20 | Daniel Wong | Integrated spot monitoring device with fluid sensor |
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US20050277849A1 (en) * | 2004-06-10 | 2005-12-15 | Daniel Wong | Vacuum sample expression device |
US20060036187A1 (en) * | 2004-06-30 | 2006-02-16 | Hester Vos | Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein |
US20060100543A1 (en) * | 2002-12-30 | 2006-05-11 | Raney Charles C | Integrated Analytical Test Element |
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US8360992B2 (en) | 2002-04-19 | 2013-01-29 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
US8372016B2 (en) | 2002-04-19 | 2013-02-12 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for body fluid sampling and analyte sensing |
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US8556829B2 (en) | 2002-04-19 | 2013-10-15 | Sanofi-Aventis Deutschland Gmbh | Method and apparatus for penetrating tissue |
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